RECRUITING

The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Spinal cord stimulation modulates the nervous system to effectively block pain signals originating from the back and legs. Spinal cord stimulation has been shown to improve chronic pain, improve quality of life, and reduce disability. Unfortunately, spinal cord stimulation has a high trial failure rate and a high long-term failure rate. This study consists of a prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy. Participants will undergo a structured optimization evaluating existing types of stimulation (tonic, burst, and multistim). Each participant will try out all types of available stimulation but be blinded to the type. Over the course of four months, each participant will evaluate each type of stimulation by reporting daily pain scores. Thompson sampling will be used to identify which setting produces the biggest improvement in pain and recommend it for future use. Participants will follow up routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.

Official Title

The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Quick Facts

Study Start:2023-10-01
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05741788

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 22 years of age or older
  2. * Scheduled to undergo spinal cord stimulation
  3. * English speaker
  4. * Baseline pain rating (NRS/VAS) \>=6
  1. * Scheduled for permanent implantation only without trial
  2. * Presence of pacemakers or other neurostimulators
  3. * Pregnant
  4. * Inability to read or use smart phone
  5. * Individuals who are unable to consent
  6. * Employees or students of PI
  7. * Prisoners

Contacts and Locations

Study Contact

David Darrow, MD
CONTACT
612-624-6666
darro015@umn.edu
Alexander Herman, MD
CONTACT
(612) 624-2867
herma686@umn.edu

Principal Investigator

David Darrow, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • David Darrow, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Chronic Pain